Abstract
BackgroundCleft palate is among the most common birth abnormalities. The success of primary surgery in the early months of life is crucial for successful feeding, hearing, dental development, and facial growth. Over recent decades, age at palatal surgery in infancy has reduced. The Timing Of Primary Surgery for cleft palate (TOPS) trial aims to determine whether, in infants with cleft palate, it is better to perform primary surgery at age 6 or 12 months (corrected for gestational age).Methods/designThe TOPS trial is an international, two-arm, parallel group, randomised controlled trial. The primary outcome is insufficient velopharyngeal function at 5 years of age. Secondary outcomes, measured at 12 months, 3 years, and 5 years of age, include measures of speech development, safety of the procedure, hearing level, middle ear function, dentofacial development, and growth. The analysis approaches for primary and secondary outcomes are described here, as are the descriptive statistics which will be reported. The TOPS protocol has been published previously.DiscussionThis paper provides details of the planned statistical analyses for the TOPS trial and will reduce the risk of outcome reporting bias and data-driven results.Trial registrationClinicalTrials.gov NCT00993551. Registered on 9 October 2009.
Highlights
Cleft palate is among the most common birth abnormalities
The primary objective is to determine whether surgery for cleft palate, using the Sommerlad technique, at age 6 months when compared to surgery at age 12 months improves velopharyngeal function at age 5 years
Velopharyngeal insufficiency is measured by Velopharyngeal Composite Score (VPC) sum, which is a sum of scores, based on three components: hypernasality, non-oral errors, and velopharyngeal insufficiency (VPI) symptoms
Summary
The success of primary surgery in the early months of life is crucial for successful feeding, hearing, dental development, and facial growth. Age at palatal surgery in infancy has reduced. The age at which palatal surgery is carried out has reduced. This has led to one-stage palatal closure within 12 months of age at cleft units in Europe and the USA. Protagonists of early closure of the palatal cleft have proposed that since speech is a learnt behaviour, the sooner an intact anatomy is created, the better [7,8,9,10]. There is no evidence that early surgery would lead to better speech development
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